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Details for New Drug Application (NDA): 018741

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NDA 018741 describes DIPROLENE, which is a drug marketed by Schering and Merck Sharp Dohme and is included in four NDAs. It is available from two suppliers. Additional details are available on the DIPROLENE profile page.

The generic ingredient in DIPROLENE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for NDA: 018741

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 018741

Suppliers and Packaging for NDA: 018741

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
betamethasone dipropionate
OINTMENT, AUGMENTED;TOPICAL 018741 NDA Merck Sharp & Dohme Corp. 0085-0575 0085-0575-02 1 TUBE in 1 BOX (0085-0575-02) > 15 g in 1 TUBE
betamethasone dipropionate
OINTMENT, AUGMENTED;TOPICAL 018741 NDA Merck Sharp & Dohme Corp. 0085-0575 0085-0575-05 1 TUBE in 1 BOX (0085-0575-05) > 50 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT, AUGMENTED;TOPICALStrengthEQ 0.05% BASE
Approval Date:Jul 27, 1983TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018741

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
betamethasone dipropionate
OINTMENT, AUGMENTED;TOPICAL018741-001Jul 27, 19834,070,462► Subscribe
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